FOI release

Freedom of Information request (FOI 22/939 )

Published 17 January 2024

© Crown copyright 2024

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-10-october-2022/freedom-of-information-request-foi-22939

10th October 2022

FOI 22/939

Dear

Thank you for your Freedom of Information request dated 01 September 2022, where you requested the following information:

  1. When did the marketing authorisation holders (MAH) of citalopram change the labelling and patient information leaflets (PIL) with regard to any reference referring to a “chemical imbalance” and what was the reason/evidence for this change.

  2. When did the marketing authorisation holders (MAH) of escitalopram change the labelling and patient information leaflets with regard to any reference referring to a “chemical imbalance” and what was the reason/evidence for this change.

  3. When did the marketing authorisation holders (MAH) of fluoxetine change the labelling and patient information leaflets with regard to any reference referring to a “chemical imbalance” and what was the reason/evidence for this change.

  4. When did the marketing authorisation holders (MAH) of paroxetine change the labelling and patient information leaflets with regard to any reference referring to a “chemical imbalance” and what was the reason/evidence for this change.

  5. When did the marketing authorisation holders (MAH) of sertraline change the labelling and patient information leaflets with regard to any reference referring to a “chemical imbalance” and what was the reason/evidence for this change.

In reply to your questions, I can confirm:

  1. The reference to the term “chemical imbalances” was added to the citalopram PIL in April 2009. The variation amended the description of how the medicine works from “Cipramil belongs to the group of medicines known as antidepressants which work by relieving the symptoms of depressed mood” to “Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants. These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.” following user testing and reformatted the PIL. Specific evidence to support the new phrase was not provided in the context of the user testing assessment.

  2. The term “chemical imbalances” is not specifically mentioned in the marketing authorisation holders (MAH) of the escitalopram PIL. The escitalopram PIL dated June 2002 mentions “these medicines help to normalize the levels of serotonin in the brain.”

  3. The term “chemical imbalances” is not specifically mentioned in the marketing authorisation holders (MAH) of fluoxetine PIL. The fluoxetine PIL from March 1999 mentions “Depression is caused by a disturbance in the chemistry of your brain…”.

  4. The term “chemical imbalances” is not specifically mentioned in the marketing authorisation holders (MAH) of paroxetine PIL. The PIL dated December 1997 mentions ‘low levels of serotonin in the brain are thought to be a cause of depression and other related conditions’.

  5. The term “chemical imbalances” is not specifically mentioned in the marketing authorisation holders (MAH) of sertraline PIL.

The wording ‘chemical imbalance’ is one of several terminologies used to explain to patients in plain English one of the several evolving scientific paradigms which have been adopted in the psychiatry scientific literature to attempt to provide the basis, in part, for complex psychiatric conditions such as depression. We are aware of several recent publications proposing other aetiological mechanisms which may form the basis for depression and related conditions. The totality of evolving evidence remains under close review and forms part on the ongoing benefit and risk balance assessments for the selective serotonin reuptake inhibitor medicines.

The terms used withing these PILs have been subject to user testing to ensure patients are able to find and understand the information provided for their medicines.

I hope the information provided is helpful; however, if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

Back to top